EUCTR2017-000066-29-DE进行中（未招募）1 期
Subject reported outcomes on satisfaction, efficacy and safety with Luxerm® in the field-directed treatment of thin or non-hyperkeratotic and non-pigmented Actinic Keratosis of the face or the scalp
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galderma R&D
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1-Male or female age above 18 years old.
- •2-Subject with at least 5 clinically confirmed thin or non-hyperkeratotic and non-pigmented actinic keratoses in an anatomical area on the face (e.g., forehead or cheek or chin) excluding nose, eyelids, lips and mucosa, or balding scalp, at baseline visit.
- •3-Subject or caregiver capable of performing the skin preparation and Luxerm? treatment application as per the investigator instructions.
- •4-Female subject of childbearing potential must have a negative UPT at baseline (UPT should have a sensitivity of 25 IU/L or less) and agree to be strictly abstinent or use a highly effective method of birth control during the study (i.e. progestogen-only oral hormonal contraception; male or female condom; cap, diaphragm or sponge with spermicide; bilateral tubal ligation; combined (estrogen and progestogen-containing) oral hormonal contraception, or injectable or implants hormonal contraception (at a stable dose for at least 1 month prior to baseline); intra-uterine devices inserted at least 1 month prior to baseline; vasectomized partner for at least 3 months prior to baseline).
- •5-Female subject of non-childbearing potential, e.g.: post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy or bilateral ovariectomy.
- •6-Subject has read and signed the approved informed consent form (ICF) prior to any participation in the study.
- •7-Subject has read and signed a Photograph Release Consent Form if he/she is willing to be photographed.
- •8-Subject (or caregiver) willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1-Subject with a clinical diagnosis of a skin disease other than AK (including non-melanoma skin cancer) on the target anatomical area.
- •2-Subject with severe AK (thick, hyperkeratotic AK) per anatomical area (face or scalp).
- •3-Subject with clinical diagnosis of other skin disease on the target anatomical area.
- •4-Subject with pigmented AK on the target anatomical area.
- •5-Subject with melanoma at any location.
- •6-Immunocompromised subject or requiring immunosuppressive therapies.
- •7-Subject with porphyria; photosensitivity- related disorders, active infectious disease.
- •8-Subject with known or suspected hypersensitivity to the active substance or to any excipients of Luxerm® (see Summary of Product Characteristics).
- •9-Female subject who is pregnant, nursing or planning a pregnancy during the study.
- •10-Subject who has used any of the following topical preparations on the area to be treated: keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g. glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
- •11-Subject with a wash-out period from baseline for topical or systemic treatment or medical/surgical procedure in the anatomical area (for AKs) less than the following:
- •Retinoids, including tazarotene, adapalene, tretinoin, retinol = 4 weeks
- •Cryotherapy, diclofenac, corticosteroids or other treatments for AK =8 weeks
- •Microdermabrasion, laser ablative treatments or chemical peels = 8 weeks
- •5-FU, imiquimod = 24 weeks
- •Surgical: excision and reconstructive surgery, chemosurgery = 12 weeks
- •Any Photodynamic Therapy, ingenol mebutate (Pep-005), Radiotherapy and UV radiation therapy = 12 weeks
- •Investigational therapies for Actinic Keratoses = 12 weeks
- •Immunosuppressive drugs (such as glucocorticoids, cytostatic, antibodies, drugs acting on interferon, opioids, TNF binding proteins, Mycophenolate, small biologics agents) = 12 weeks
- •12-Subject who is currently participating to/ or who has participated in another investigational treatment or device research study within 4 weeks of baseline visit.
- •13-Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- •14-Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- •15-Subject who is unwilling to refrain from use of prohibited medication during the clinical trial (see section 4.3.5).
- •16-Subject who is vulnerable (such as deprived of freedom) as defined in Section 1.61 of the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).
- •17-Subject with clinically significant abnormal laboratory finding (if any available report) at the baseline visit or medical/surgical condition (other than for actinic keratoses), which might, in the Investigator’s opinion, interfere with study evaluations or pose a risk to subject safety during the study.
- •18-The subject is a study site staff member (investigator, study nurse, etc.) or a relative of one.
- •19-Subjects with any condition that may be associated with a risk of poor protocol compliance
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